Asks Pharmaceutical Companies to Make Patient Level Data Available
Christine Feheley firstname.lastname@example.org 703-253-4374
Lisa Gibson email@example.com 703-549-1500, ext. 4824
The American Diabetes Association (the Association) is asking all pharmaceutical companies involved in the development or marketing of incretin-based medications, used to lower blood glucose levels, to make patient-level data on their products available for an independent review that could help settle the question of whether such therapies contribute to the development of pancreatitis or pancreatic cancer.
Incretin therapy refers to medications such as GLP-1 receptor agonists and DPP-4 inhibitors, which are used to improve diabetes control and increase weight loss, either alone or in conjunction with other medications such as metformin or insulin. Recent publications have intensified the controversy surrounding the potential role of incretin therapy in the development of pancreatitis and pancreatic neoplasia in people with type 2 diabetes.
“The Association is committed to improving the lives of all people with diabetes, ensuring that a broad spectrum of safe and effective therapies are available to meet their personal health needs,” said Robert Ratner, MD, FACP, FACE, Chief Scientific & Medical Officer, American Diabetes Association. “People who are taking these medications, or who may consider taking them, should have the benefit of all that is currently known about their risks and advantages in order to make the best possible decisions about their treatment and care in consultation with their health care providers.”
A great deal of controversy has recently arisen around the role of incretins as a possible cause of pancreatitis and pancreatic neoplasia. Administrative database analyses suggest either no effect on pancreatitis or a small risk associated with incretin therapy, but it is less than that due to obesity or alcohol ingestion. A recent case control trial examining autopsy specimens suggested that exposure to sitagliptin or exenatide in a small number of subjects increased neoplastic changes in the pancreas of subjects with type 2 diabetes to a greater extent than that seen in nondiabetes subjects or diabetic patients treated with drugs other than incretins. This analysis has been criticized from a methodologic standpoint and remains unconfirmed.
To provide clarity for patients and health care providers in this controversial area, the Association is proposing that an independent review of available clinical and pathologic data be conducted. Toward this end, the Association is calling on all pharmaceutical companies with incretin therapies in development or currently marketed to make patient-level data available on all subjects involved in regulatory trials for an independent analysis. The Association proposes to release a call for applications from academic and research organizations capable of integrating large experimental databases to illuminate the potential role of incretin therapy in pancreatic pathology.
The American Diabetes Association is leading the fight to Stop Diabetes and its deadly consequences and fighting for those affected by diabetes. The Association funds research to prevent, cure and manage diabetes; delivers services to hundreds of communities; provides objective and credible information; and gives voice to those denied their rights because of diabetes. Founded in 1940, our mission is to prevent and cure diabetes and to improve the lives of all people affected by diabetes. For more information please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit www.diabetes.org. Information from both these sources is available in English and Spanish.